(29 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, pegs, wires) and surgical instruments. There is no mention of software, algorithms, or any technology that would suggest AI/ML. The performance studies are based on material standards and mechanical comparisons, not algorithmic performance.
Yes
The device is described as a "Distal Radius Fracture Repair System" intended for the "fixation of fractures and osteotomies involving the distal radius," which directly addresses a health condition (fractures) and aims to restore or improve a body function (bone integrity).
No
The device is described as a repair system for fractures and osteotomies, which are therapeutic interventions rather than diagnostic processes. It consists of plates, screws, and pegs used for fixation, which are components for treatment, not for diagnosing conditions.
No
The device description explicitly details physical components made of titanium and stainless steel, including plates, screws, pegs, and surgical instruments. There is no mention of software as a component of this system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the fixation of fractures and osteotomies involving the distal radius." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates, screws, pegs, and instruments used for bone fixation. These are all surgical implants and tools, not devices used to examine specimens from the human body.
- No mention of in vitro testing: The text does not describe any process of analyzing samples (blood, tissue, etc.) outside of the body.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device is a surgical implant and instrument system used for the mechanical repair of bone fractures.
N/A
Intended Use / Indications for Use
The Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
LXT
Device Description
The Distal Radius Fracture Repair System (DRFRS) was previously cleared under 510(k) No. K030198. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed angle bone pegs and two locking screws. This 510(k) is being submitted as a modification to the original 510(k) No. K030198 in order to add accessories to the DRFRS.
The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s).
The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft.
Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig drill guide, screw jig and screw guide.
A standard awl, which is a manual surgical instrument, used to enlarge t or tunnel by rotary movement is a catalog item manufactured by K-Medic (catalog no. KM-48-336).
This submission describes two accessories that are being added to the Distal Radius Fracture Repair Systems, fragment plates and a "K-Type" wire.
The fragment plates are essentially smaller implementations of the existing Distal Dorsal Nail-Plates and Distal Volar Radius Plates. The fragment plates are intended for the attachment of small bone fragment plates will be available in the four versions: right, left, straight, and "Y." The fragment plates are made from the same titanium (ASTM F 136 - 96) as the existing Distal Dorsal Nail-Plates and Distal Volar Radius Plates cleared via K030198. The plates are intended to be fastened to bone using the 2.5 mm titanium screws that were cleared via K030198.
The K-Wires that will be supplied with the Distal Radius Fracture Repair System are primarily intended for intraoperative use to temporarily locate bone plates or for interfragmental fixation. Even though the K-Wire is intended primarily for intraoperative use, if desired by the surgeon, the K-Wires may permanently implanted. The K-Wires are made from the same titanium (ASTM F 136 - 96) as the existing pins and screws.
Three variations of the right and left distal volar plates have been added to accommodate the anatomies of larger and smaller patients. The list of manual surgical instruments included in the Distal Radius Fracture Repair System has been updated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Hand Innovations, Inc. Distal Radius Fracture Repair Systems comply with the following standards, practices, and guidances:
- ASTM F366 82 (Reapproved 2000), Standard Specification for Fixation . Pins and Wires
- ASTM F 136 96, Standard Specification for Wrought Titanium-6 Alu-. minum-4 Vanadium ELI (Extra Low Interstitial) Alloy (R56401) for Surgical Implant Applications.
The Hand Innovations, Inc. Distal Radius Fracture Repair System is substantially equivalent to Distal Volar Fracture Repair System that is legally marketed and distributed by Hand Innovations, Inc. This has been demonstrated through a 15-point technological comparison of features and a 3-parameter comparison of mechanical performance.
The implantable and tissue contact materials used to fabricate the Distal Radius Fracture Repair System and Instruments have a long history of safe usage in medical devices. Since the Hand Innovations, Inc. Distal Radius Fracture Repair Systems meet the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The Distal Radius Fracture Repair System will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
OCT = 1 2003
OCT-1 2003
Summary of Safety and Effectiveness
for the
Distal Radius Fracture Repair System
page 1 of 3
submitted by Hand Innovations, Inc. 8905 SW 87 Avenue Miami, FL 33176-2227 Phone: 1 (800)-800-8188
| Contact Person: | Al Weisenborn |
|---|---|
| Device Trade Name: | Distal Radius Fracture Repair System |
| Common Name: | Distal Volar Radius Plate, Dorsal Nail Plate and Jig Set |
| Classification Name: | Plate Fixation Bone per 21 CFR § 888.3030 |
Identification of a Legally Marketed Predicate Device
The Hand Innovations, Inc. Distal Radius Fracture Repair System is substantially equivalent to Distal Volar Fracture Repair System that is legally marketed and distributed by Hand Innovations, Inc.
Device Description
The Distal Radius Fracture Repair System (DRFRS) was previously cleared under 510(k) No. K030198. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed angle bone pegs and two locking screws. This 510(k) is being submitted as a modification to the original 510(k) No. K030198 in order to add accessories to the DRFRS.
The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s).
The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft.
Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig drill guide, screw jig and screw guide.
1
K032705
page 2 of 3
A standard awl, which is a manual surgical instrument, used to enlarge t or tunnel by rotary movement is a catalog item manufactured by K-Medic (catalog no. KM-48-336).
Description of Modifications
This submission describes two accessories that are being added to the Distal Radius Fracture Repair Systems, fragment plates and a "K-Type" wire.
The fragment plates are essentially smaller implementations of the existing Distal Dorsal Nail-Plates and Distal Volar Radius Plates. The fragment plates are intended for the attachment of small bone fragment plates will be available in the four versions: right, left, straight, and "Y."
The fragment plates are made from the same titanium (ASTM F 136 - 96) as the existing Distal Dorsal Nail-Plates and Distal Volar Radius Plates cleared via K030198. The plates are intended to be fastened to bone using the 2.5 mm titanium screws that were cleared via K030198.
The K-Wires that will be supplied with the Distal Radius Fracture Repair System are primarily intended for intraoperative use to temporarily locate bone plates or for interfragmental fixation.
Even though the K-Wire is intended primarily for intraoperative use, if desired by the surgeon, the K-Wires may permanently implanted. The K-Wires are made from the same titanium (ASTM F 136 - 96) as the existing pins and screws.
Three variations of the right and left distal volar plates have been added to accommodate the anatomies of larger and smaller patients. The list of manual surgical instruments included in the Distal Radius Fracture Repair System has been updated.
Intended Use
The Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius.
Summary of Technological Characteristics
A 15-point comparison of technological characteristics of the Hand Innovations, Inc. Distal Radius Fracture Repair System and the predicate device was performed. The devices were found to be substantially equivalent.
Summary of Performance Data
The Hand Innovations, Inc. Distal Radius Fracture Repair Systems comply with the following standards, practices, and guidances:
2
- ASTM F366 82 (Reapproved 2000), Standard Specification for Fixation . Pins and Wires
- ASTM F 136 96, Standard Specification for Wrought Titanium-6 Alu-. minum-4 Vanadium ELI (Extra Low Interstitial) Alloy (R56401) for Surgical Implant Applications.
The Hand Innovations, Inc. Distal Radius Fracture Repair System is substantially equivalent to Distal Volar Fracture Repair System that is legally marketed and distributed by Hand Innovations, Inc. This has been demonstrated through a 15-point technological comparison of features and a 3-parameter comparison of mechanical performance.
The implantable and tissue contact materials used to fabricate the Distal Radius Fracture Repair System and Instruments have a long history of safe usage in medical devices. Since the Hand Innovations, Inc. Distal Radius Fracture Repair Systems meet the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The Distal Radius Fracture Repair System will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT = 1 2003
Mr. Al Weisenborn Hand Innovations, Inc. 8905 SW 87 Avenue Miami, FL 33176-2227
Re: K032705
Trade/Device Name: Distal Radius Fracture Repair System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: August 27, 2003 Received: September 2, 2003
Dear Mr. Weisenborn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Al Weisenborn
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark N Milkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use of Use
Page 1 of 1
KO3270 510(k) Number (if known):
Device Name: Distal Radius Fracture Repair System
Indications for Use:
The Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius.
Mark A Millen
of General. Restorative ological Devices
510(k) Nomber
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ X (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
405